Adjustable stop for elongate medical device deflection mechanism

ABSTRACT

A deflection mechanism for an elongate medical device may comprise an actuator. The actuator may comprise a rotatable body comprising a channel, the channel comprising a plurality of recesses. The deflection mechanism may further comprises an activation wire having a proximal end and a distal end, and a wire lock attached to the proximal end of the activation wire. The wire lock may be disposed within the channel and configured to ride therein when the actuator body is rotated. An adjustable stop may be placed in one or more of the recesses of the channel so as to apply a force to the wire lock as the actuator is rotated so as to increase tension on the activation wire.

BACKGROUND

a. Technical Field

This disclosure relates to elongate medical devices, such as, forexample and without limitation, catheters and sheaths or introducers.More particularly, this disclosure relates to deflection mechanisms forsuch elongate medical devices, and elongate medical devices andcomponents thereof that include such deflection mechanisms.

b. Background Art

It is known to use elongate medical devices, such as, for example,catheters and sheaths or introducers, when performing varioustherapeutic and/or diagnostic medical procedures on or in variousanatomical structures of a patient's body, such as, for example, theheart. Such devices generally include an elongate shaft having aproximal end portion and a distal end portion, and a handle assemblydisposed at the proximal end portion of the shaft. In order to preciselylocate and position these devices within the anatomy of the patient, thedevices may include means by which the device may be steered or guidedas it travels within and through the patient's body. More particularly,these devices may include, among other components, deflection mechanismsthat may be manipulated and controlled by a user or physician to allowfor the precise locating and positioning of the device.

In general terms, such deflection mechanisms typically include, at leastin part, an actuator and one or more activation wires. The actuator,which is generally associated with the handle assembly of the elongatemedical device, is coupled to the activation wires and is configured tocause tension to be selectively applied thereto in order to deflect theshaft of the device in one or more directions. More particularly, eachof the activation wires comprises a proximal end and a distal end. Theproximal ends of the activation wires are coupled to the actuator, whilethe distal ends are coupled to one or more pull assemblies disposed ator near the distal end portion of the shaft of the device. As theactuator is manipulated, one or more of the activation wires may beselectively tensioned, thereby effecting movement of the pull assembly,and thus, the deflection of the shaft.

For example, in one conventional deflection mechanism, the actuatorthereof comprises one or more posts that are each configured to becoupled to the proximal end of a respective activation wire. Forexample, in an instance wherein the deflection mechanism comprises apair of activation wires, the actuator may include a pair of posts, eachone of which has a respective one of the activation wires coupledthereto. In such an instance, as the actuator is manipulated to deflectthe shaft in a desired direction, a pulling force is applied onto one ofthe activation wires, thereby causing tension to be applied to thatactivation wire, while a pushing force is applied to the other of thetwo activation wires.

The foregoing discussion is intended only to illustrate the presentfield and should not be taken as a disavowal of claim scope.

BRIEF SUMMARY

An embodiment of a deflection mechanism for use in an elongate medicaldevice may comprise an actuator comprising a rotatable body, the bodycomprising a channel, the channel comprising a plurality of recesses,and an adjustable stop disposed in at least one of the recesses. Thedeflection mechanism may further comprise an activation wire having aproximal end and a distal end, and a wire lock attached to the proximalend of the activation wire. The wire lock may be disposed within thechannel and may be configured to ride within the channel when theactuator body is rotated so as to increase tension on the activationwire.

An embodiment of a handle assembly for use in a steerable elongatemedical device may comprise a housing defining a cavity and a deflectionmechanism. The deflection mechanism may comprise an actuator comprisinga rotatable body at least a portion of which is disposed within thecavity of the housing, the body comprising a channel. The deflectionmechanism may further comprise an activation wire having a proximal endand a distal end, a wire lock attached to the proximal end of theactivation wire, and an adjustable stop disposed across the channel soas apply a force to the wire lock responsive to actuation of saidactuator. The channel may be configured to allow placement of the wirestop at multiple locations. The wire lock may be disposed within thechannel and may be configured to ride therein when the actuator body isrotated. The activation wire may extend from the channel and into thecavity of the housing.

An embodiment of a method of manufacturing a handle assembly for anelongate medical device may comprise extending a proximal end of anactivation wire into a channel of a rotatable body of the handleassembly and placing an adjustable stop in one or more of a plurality ofrecesses in the channel such that the activation wire extends through anopening in the adjustable stop and a wire lock at a proximal end of theactivation wire cannot extend distally beyond the adjustable stop.

The foregoing and other aspects, features, details, utilities, andadvantages of the present disclosure will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of an exemplary elongate medical device inaccordance with the present teachings.

FIG. 2 is an exploded view of the exemplary elongate medical deviceillustrated in FIG. 1.

FIG. 3A is an isometric view of portions of the handle assembly anddeflection mechanism of the elongate medical device illustrated in FIGS.1 and 2 when the elongate medical device is in a neutral ornon-deflected state.

FIG. 3B is an isometric view of portions of the handle assembly anddeflection mechanism of the elongate medical device illustrated in FIGS.1 and 2 when the elongate medical device is in a deflected state.

FIG. 4 is an isometric view of the base member of an exemplary actuatorbody of the deflection mechanism illustrated in FIGS. 1-3B.

FIG. 5A is a plan view of a first face of the actuator body base memberillustrated in FIG. 4.

FIG. 5B is an enlarged plan view of a portion of the actuator body basemember illustrated in FIG. 5A.

FIG. 6 is a cross-section view of an exemplary actuator of thedeflection mechanism illustrated in FIGS. 1 and 2 taken along line 6-6in FIG. 1.

FIGS. 7A and 7B are isometric views of portions of the elongate medicaldevice illustrated in FIG. 1 showing the distal end portion of the shaftof the elongate medical device deflected in different directions.

FIG. 8A is a side view of an exemplary embodiment of a wire lock of thedeflection mechanism illustrated in FIGS. 1 and 2.

FIG. 8B is a cross-section view of the wire lock illustrated in FIG. 8Ataken along the line 8B-8B in FIG. 8A.

FIG. 9A is an isometric view of an embodiment of an adjustable stop.

FIG. 9B is a side view of the adjustable stop of FIG. 9A.

FIG. 9C is a bottom view of the adjustable stop of FIGS. 9A and 9B.

FIG. 10A is an isometric view of an embodiment of an adjustable stop.

FIG. 10B is a side view of the adjustable stop of FIG. 10A.

FIG. 10C is a top view of the adjustable stop of FIGS. 10A and 10B.

FIG. 11A is an isometric view of an embodiment of an adjustable stop.

FIG. 11B is a side view of the adjustable stop of FIG. 11A.

FIG. 11C is a top view of the adjustable stop of FIGS. 11A and 11B.

DETAILED DESCRIPTION OF EMBODIMENTS

Various embodiments are described herein of various apparatus and/orsystems. Numerous specific details are set forth to provide a thoroughunderstanding of the overall structure, function, manufacture, and/oruse of the embodiments as described in the specification and illustratedin the accompanying drawings. It will be understood by those skilled inthe art, however, that the embodiments may be practiced without suchspecific details. In other instances, well-known operations, components,and elements have not been described in detail so as not to obscure theembodiments described in the specification. Those of ordinary skill inthe art will understand that the embodiments described and illustratedherein are non-limiting examples, and thus it can be appreciated thatthe specific structural and functional details disclosed herein may berepresentative and do not necessarily limit the scope of theembodiments, the scope of which is defined solely by the appendedclaims.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” “an embodiment,” “an exemplaryembodiment,” or the like, means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in variousembodiments,” “in some embodiments,” “in one embodiment,” “in anembodiment,” “in an exemplary embodiment,” or the like, in placesthroughout the specification are not necessarily all referring to thesame embodiment. Furthermore, the particular features, structures, orcharacteristics may be combined in any suitable manner in one or moreembodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation given that such combination is not illogical ornon-functional.

It will be appreciated that the terms “proximal” and “distal” may beused throughout the specification with reference to a clinicianmanipulating one end of an instrument used to treat a patient. The term“proximal” refers to the portion of the instrument closest to theclinician and the term “distal” refers to the portion located furthestfrom the clinician. It will be further appreciated that for concisenessand clarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the illustrated embodiments.However, surgical instruments may be used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

Referring now to the drawings wherein like reference numerals are usedto identify identical or similar components in the various views, FIG. 1illustrates one exemplary embodiment of an elongate medical device 10that is configured to be deflected in one or more directions. Theelongate medical device 10 may comprise, for example, a diagnosticand/or therapy delivery catheter, an introducer or sheath, or other likedevices. For purposes of illustration and clarity, the description belowwill be with respect to an embodiment wherein the device 10 comprises acatheter (i.e., catheter 10). It will be appreciated, however, thatembodiments wherein the device 10 comprises elongate medical devicesother than a catheter remain within the spirit and scope of the presentdisclosure.

With continued reference to FIG. 1, in an exemplary embodiment, thecatheter 10 is configured to be inserted into a patient's body, and moreparticularly, into the patient's heart. The catheter 10 may include ahandle assembly or handle 12, a shaft 14 having a proximal end portion16 and a distal end portion 18, and one or more sensors 20 mounted in oron the shaft 14. In an exemplary embodiment, the sensor(s) 20 is/aredisposed at the distal end portion 18 of the shaft 14. The catheter 10may further include other conventional components such as, for exampleand without limitation, a temperature sensor, additional sensors orelectrodes, ablation elements (e.g., ablation tip electrodes fordelivering RF ablative energy, high intensity focused ultrasoundablation elements, etc.), and corresponding conductors or leads.

In an exemplary embodiment, the catheter 10 further comprises one ormore electromechanical connectors 22 configured to allow the catheter10, and the sensor(s) 20 thereof, in particular, to be coupled withcomponents or subsystems of, for example, an electrophysiology (EP)laboratory system. Such components or subsystems may comprise, forexample and without limitation, a visualization, navigation, and/ormapping system, an EP monitoring and recording system (e.g., formonitoring and/or recording electrocardiograms (EGM), cardiac signals,etc.), a tissue contact sensing system, an ablation system, a cardiacstimulation system (i.e., EP stimulator), and the like.

The handle 12 is disposed at the proximal end portion 16 of the shaft14. The handle 12 provides a location for the clinician to hold thecatheter 10 and, as will be described in greater detail below, mayfurther provide means for steering or guiding the shaft 14 within thebody of a patient.

As illustrated in FIGS. 1 and 2, the handle 12 comprises a housing 24.The housing 24 may be of a unitary construction or may be constructed ofa plurality of pieces that are configured to be assembled together. Forexample, and as illustrated in FIG. 2, the housing 24 may comprise afirst or bottom piece 26 and a second or top piece 28. In such anembodiment, the first and second pieces 26, 28 of the housing 24 may becoupled together in any number of ways known in the art, such as, forexample, by press fit or interference coupling techniques, bycomplementary interlocking members disposed on each piece 26, 28 of thehousing 24, by conventional fasteners or adhesives, or any othertechniques known in the art.

Whether the housing 24 is formed of one or multiple pieces, the housing24 comprises an inner surface 30 that defines a cavity 32 in the housing24 that, as will be described below, is configured to house variouscomponents of the catheter 10 (e.g., the connector 22, variouscomponents of a deflection mechanism that will be described below,etc.). In an exemplary embodiment, and for purposes that will bedescribed in greater detail below, the housing 24 further includes apost 34 protruding from the inner surface 30 and into the cavity 32. Forpurposes that will also be described more fully below, the housing 24may further comprise a pair of guide walls 36 ₁, 36 ₂ extending orprotruding from the inner surface 30 of the housing 24 and into thecavity 32. In such an embodiment, and as shown in FIGS. 3A and 3B, theguide walls 36 ₁, 36 ₂ are located between the proximal end portion 16of the shaft 14 and the post 34. In any event, the handle 12 may beformed of conventional materials such as various types of plastics thatare well known in the art.

The shaft 14 of the catheter 10 is an elongate, tubular, flexible memberconfigured for movement within the body of the patient. The shaft 14supports, for example and without limitation, sensors and/or electrodesmounted thereon, such as, for example, the sensor(s) 20, associatedconductors, and possibly additional electronics used for signalprocessing and conditioning. The shaft 14 may also permit transport,delivery, and/or removal of fluids (including irrigation fluids,cryogenic ablation fluids, and bodily fluids), medicines, and/orsurgical tools or instruments. An example of an irrigated shaft andassociated catheter components is described in U.S. patent applicationSer. No. 13/594,104, filed Aug. 24, 2012, incorporated herein byreference in its entirety as though fully set forth herein. The shaft 14may be made from conventional materials such as polyurethane, and maydefine one or more lumens configured to house and/or transportelectrical conductors, fluids, activation or steering wires, or surgicaltools. In an embodiment wherein the catheter 10 is a diagnostic and/ortherapeutic catheter, the shaft 14 may be introduced into a blood vesselor other structure within the body of a patient through a conventionalintroducer or sheath. As will be described in greater detail below, theshaft 14 may then be steered or guided through the body to a desiredlocation, such as the heart.

The sensor(s) 20 mounted in or on the shaft 14 of the catheter 10 may beprovided for a variety of diagnostic and therapeutic purposes including,for example and without limitation, electrophysiological studies,pacing, cardiac mapping, and ablation. In an exemplary embodiment, oneor more of the sensors 20 are provided to perform a location or positionsensing function. More particularly, and as will be described in greaterdetail below, one or more of the sensors 20 are configured to be apositioning sensor that provides information relating to the location(position and orientation, or “P&O”) of the catheter 10, and the distalend portion 18 of the shaft 14 thereof, in particular, at certain pointsin time. Accordingly, in such an embodiment, as the catheter 10 is movedalong a surface of a structure of interest of the heart and/or about theinterior of the structure, the sensor(s) 20 can be used to collectlocation data points that correspond to the surface of, and/or otherlocations within, the structure of interest. These location data pointscan then be used for a number of purposes such as, for example andwithout limitation, the construction of surface models of the structureof interest.

With reference to FIGS. 1 and 2, the electromechanical connector 22provides electrical and mechanical connection(s) for, among otherthings, the leads of the sensor(s) 20 of the catheter 10, as well aswires or cables extending between the catheter 10 and other componentsof, for example, an EP laboratory system. In an exemplary embodiment,and as illustrated in FIGS. 1 and 2, the connector 22 is disposed withinthe handle 12 of the catheter 10, and within the housing 24 thereof, inparticular. For example, the connector 22 may be disposed within thecavity 32, and therefore, between the first and second pieces 26, 28 ofthe housing 24. Alternatively, and as illustrated in FIG. 2, theconnector 22 may be disposed within a cavity defined by third and fourthpieces 38, 40 of the handle housing 24. In another exemplary embodiment,rather than being disposed within or as part of the handle 12, theconnector 22 may be disposed apart from the handle 12, such as, forexample, at the end of a pigtail (not shown) extending from the handle12 of the catheter 10.

In addition to the components described above, in an exemplaryembodiment, the catheter 10 further comprises a deflection mechanism 42associated with the handle 12 of the catheter 10, and a pull assembly 44(best shown in FIGS. 7A and 7B) disposed at or in the distal end portion18 of the shaft 14 of the catheter 10. As will be described more fullybelow, the combination of the deflection mechanism 42 and the pullassembly 44 provides a means by which a user or physician can effectmovement (e.g., deflection) of the distal end portion 18 of the shaft 14in one or more directions, and therefore, allows the physician to steerthe catheter 10.

With reference to FIGS. 2-3B, in an exemplary embodiment, the deflectionmechanism 42 comprises, at least in part, an actuator 46 comprising arotatable body 48 and one or more activation or steering wires 50. Forpurposes of clarity and illustration, the description below will belimited to an embodiment wherein the deflection mechanism 42 comprisesfirst and second activation wires 50 (i.e., first activation wire 50 ₁and second activation wire 50 ₂). It will be appreciated, however, thatin other exemplary embodiments, the deflection mechanism 42 may comprisemore or less than two activation wires, and therefore, such embodimentsremain within the spirit and scope of the present disclosure.

In the embodiment illustrated in FIGS. 2-3B, and in general terms, therotatable actuator body 48, which may be constructed of, for example,molded plastic, comprises a first outer wall 52, a second outer wall 54that is substantially parallel to the first outer wall 52, and a thirdouter wall 56 that is transverse to and disposed between the first andsecond outer walls 52, 54. The actuator body 48 further comprises afirst portion 58 having a slot 60 (best shown in FIG. 2) formed thereinand a second portion 62 having a channel 64 disposed therein or thereon(best shown in FIGS. 3A and 3B). In an exemplary embodiment, and as willbe described more fully below, the first portion 58 comprises a portionof the third outer wall 56 of the rotatable body 48 and the secondportion 62 comprises an inner surface of one of the first and secondouter walls 52, 54 of the rotatable body 48. Further, in an exemplaryembodiment, the first and second portions 58, 62 of the body 48 aredisposed at opposite ends of the body 48. As illustrated in FIGS. 3A and3B, when the deflection mechanism 42 is assembled, the activation wires50 ₁, 50 ₂ extend from the channel 64 and out of the rotatable body 48through the slot 60.

More particularly, each of the activation wires 50 ₁, 50 ₂ has aproximal end 66 and a distal end 68 (best shown in FIGS. 7A and 7B). Inan exemplary embodiment, the deflection mechanism 42 further comprises apair of anchors or wire locks 70. As illustrated, for example, in FIGS.3A and 3B, each of the wire locks 70 is attached to the proximal end 66of a respective activation wire 50 (i.e., a first wire lock 70 ₁ isattached to the proximal end 66 of the first activation wire 50 ₁, and asecond wire lock 70 ₂ is attached to the proximal end 66 of the secondactivation wire 50 ₂). The wire locks 70 may be attached to the proximalends 66 of the activation wires 50 in any number of ways. In oneembodiment that is provided for exemplary purposes only and is not meantto be limiting in nature, each wire lock 70 is soldered onto theproximal end 66 of a respective activation wire 50. More particularly,in an embodiment such as that illustrated in FIGS. 8A and 8B, each wirelock 70 comprises a bore 71 therein within which the proximal end 66 ofa corresponding activation wire 50 may be inserted and then soldered inplace. It will be appreciated, however, that any number of attachmenttechniques that are well known in the art may be used instead of asoldering technique to attach the wire locks 70 to the proximal ends 66of the activation wires 50, and such other techniques remain within thespirit and scope of the present disclosure. The wire locks 70 mayalternatively be formed on or otherwise positioned along its respectiveactivation wire 50 (e.g., at or near the proximal end 66 of itsrespective activation wire), such as, for example, by forming a knot inthe respective activation wire 50. Other embodiments that do not utilizeseparate wire locks 70 may also be employed. For example, an activationwire may be secured to its respective adjustable stop (see, e.g., stops132 ₁, 132 ₂ described in more detail below), such as by tying theactivation wire around its respective adjustable stop.

As will be described in greater detail below, while the proximal ends 66of the activation wires 50 are disposed within the actuator body 48 whenthe actuator 46 is assembled, the distal ends 68 of the activation wires50 ₁, 50 ₂ are coupled or attached to, for example, the pull assembly 44disposed within the shaft 14 of the catheter 10 (best shown in FIGS. 7Aand 7B).

With continued reference to FIGS. 3A and 3B, in an exemplary embodiment,the channel 64 of the actuator body 48 includes a plurality of recesses124 ₁, 124 ₂, 124 ₃, 124 ₄, 124 ₅, 124 ₆, 126 ₁, 126 ₂, 126 ₃, 126 ₄,126 ₅, 126 ₆ (which may be referred to collectively as recesses 124,126). For visual clarity, not all recesses 124, 126 are labeled in allfigures, though all those illustrated are labeled in FIG. 3A. In anembodiment, the recesses are arranged in opposed pairs. For example, afirst portion 128 of the channel 64 may include a first pair of opposedrecesses 124 ₁, 124 ₂, a second pair of opposed recesses 124 ₃, 124 ₄,and a third set of opposed recesses 124 ₅, 124 ₆. A second portion 130of the channel 64 may similarly include a first pair of opposed recesses126 ₁, 126 ₂, a second pair of opposed recesses 126 ₃, 126 ₄, and athird set of opposed recesses 126 ₅, 126 ₆. Of course, a differentnumber of recesses 124, 126 may be provided in one or both of the firstand second channel portions 128, 130, in an embodiment. The recesses124, 126 may comprise, in an embodiment, rectangular or squared notches.In a respective set of opposed recesses in each of the first and secondportions 128, 130 of the channel 64, adjustable stops 132 ₁, 132 ₂ maybe disposed so as to span the channel 64 substantially perpendicular tothe channel 64 (i.e., perpendicular to the direction of movement of theactivation wires 50 ₁, 50 ₂ and the wire locks 70 ₁, 70 ₂ within thechannel). Accordingly, opposed recesses (for example, first opposedrecesses 124 ₁, 124 ₂, 126 ₃, 126 ₄) may be configured so that a firstrecess 124 ₁, 126 ₃ receives a first end 134 (see FIGS. 9A-11C) of anadjustable stop 132 ₁, 132 ₂, and an opposed recess 124 ₂, 126 ₄receives a second end 136 (see FIGS. 9A-11C) of an adjustable stop 132₁, 132 ₂. While the recesses in the embodiment depicted in FIGS. 3A and3B are shown in pairs on opposing sides of the channel 64, in anotherembodiment, the recesses may only be positioned on only one side of thechannel 64, such that the adjustable stop(s) may each be received ononly one end 134 or 136 by a recess 124, 126.

The adjustable stops 132 ₁, 132 ₂ may be provided to ease themanufacturing and assembly processes of the catheter 10, and moreparticularly of the handle 12. During known manufacturing processes, theactivation wires 50 ₁, 50 ₂ generally must be cut to an exact length toensure that a neutral (i.e., non-rotated) state of the deflectionmechanism 42 results in a neutral (i.e., non-deflected) position of theshaft 14. In known construction and assembly methods, tolerances for thelength of the activation wires 50 ₁, 50 ₂ are generally tight. If anactivation wire 50 ₁, 50 ₂ is too short, it may not extend sufficientlyfar into the channel 64, such that the neutral position of thedeflection mechanism 42 is incorrect. If an activation wire 50 ₁, 50 ₂is too long, it may extend too far into the channel 64 such that thedeflection mechanism 42 does not enable the full range of deflectionneeded for the shaft 14.

With the adjustable stops 132 ₁, 132 ₂, the length tolerance for theactivation wires 50 ₁, 50 ₂ may be eased. The activation wires 50 ₁, 50₂ may be designed and intended to have a length such that eachactivation wire 50 ₁, 50 ₂ (i.e., the wire locks 70 ₁, 70 ₂ thereof)reaches, for example only, a second set of opposed recesses (i.e.,recesses 124 ₃, 124 ₄ in the first channel portion 128 and recesses 126₃, 126 ₄ in the second channel portion 130). If the activation wire 50₁, 50 ₂ is cut to the intended length, the adjustable stops 132 ₁, 132 ₂can be placed in recesses 124 ₃, 124 ₄, 126 ₃, 126 ₄. If each of theactivation wires 50 ₁, 50 ₂ is too long, the appropriate adjustable stop132 ₁, 132 ₂ may be placed in the third set of opposed recesses (i.e.,recesses 124 ₅, 124 ₆ or 126 ₅, 126 ₆). If one of the activation wires50 ₁, 50 ₂ is too short, the appropriate adjustable stop may be placedin the first set of opposed recesses (i.e., recesses 124 ₁, 124 ₂ or 126₁, 126 ₂) or removed from the channel 64 entirely.

It should be understood that the placement of each adjustable stop 132₁, 132 ₂ will be dictated by the length of each activation wire 50 ₁, 50₂. Accordingly, the adjustable stops 132 ₁, 132 ₂ may be placed indifferent positions in the channel 64 (i.e., a first stop 132 ₁ may beplaced in a first set of opposed recesses 124 ₁, 124 ₂, and a secondstop 132 ₂ placed in a second set of opposed recesses 126 ₃, 126 ₄) or,as noted above, one or both of the adjustable stops 132 ₁, 132 ₂ may beremoved entirely.

It should further be understood that features in addition to or insteadof recesses 124, 126 may be provided, in an embodiment, to allowplacement of the adjustable stops 132 ₁, 132 ₂. Accordingly, in anembodiment, the channel 64 may comprise structures and/or features inaddition to or instead of the recesses 124, 126. For example, in anembodiment, the channel 64 may comprise inwardly-projecting tabsconfigured to hold an adjustable stop 132 in place. Suchinwardly-projecting tabs may narrow the diameter of the channel 64. Theinwardly-projecting tabs may be rectangular, in an embodiment, or mayinclude some other shape or configuration. In an embodiment, the tabsmay configured to eliminate the need for adjustable stops 132—i.e., asufficient number of tabs may be included in the channel that virtuallyany neutral position length of an activation wire 152 would result in aset of inwardly-projecting tabs just proximal of the wire lock 70. Insuch an embodiment, one or more tabs may directly prevent a wire lock 70from translating proximally beyond the one or more tabs.

FIGS. 9A-9C illustrate a first embodiment of the adjustable stops 132 ₁,132 ₂ (i.e., adjustable stop 132). FIG. 9A is an isometric view of thestop 132, FIG. 9B is a “bottom” view of the stop 132, and FIG. 9C is a“side” view of the stop 132. The stop 132 may comprise a rectangularprism, in an embodiment, including the first end 134, the second end136, a first, proximal face 138, a second, distal face 140, a third,upper face 142, a fourth, lower face 144, two end faces 146, 148, and anopening 150 extending from the proximal face 138 to the distal face 140.The relative dimensions of the faces 138, 140, 142, 144, 146, 148 may betailored to a particular application (i.e., the particular dimensions ofthe channel 64 and recesses 124, 126), and thus the stop 132 is notlimited to the relative dimensions illustrated. The first and secondends 134, 136 of the stop may be generally squared, i.e., the end faces146, 148 may be generally perpendicular to the proximal face 138, thedistal face 140, the upper face 142, and the lower face 144. The opening150 may be configured in size and shape to allow an activation wire(i.e., one of the activation wires 50 ₁, 50 ₂ in FIGS. 3A and 3B) totranslate through or otherwise relative to the stop 132. The opening 150may thus be larger in diameter than the activation wires 50 ₁, 50 ₂. Theopening 50 may be further configured in size and shape to prevent a wirelock 70 ₁, 70 ₂ from passing through or past the stop 132. Thus, thesize or diameter of the opening 150 may be smaller than a size or adiameter d₃ of the wire locks 70 ₁, 70 ₂ (see FIGS. 8A and 8B). In anembodiment, during manufacturing, activation wires may be pulled tautwithin a channel (i.e., the channel 64, see FIGS. 3A-5B) and the stops132 ₁, 132 ₂ may be placed “down” in one or more recesses 124, 126,distal of the wire locks at the proximal end of the activation wires,with a respective activation wire passing through a respective opening150.

The opening 150 may take any number of forms. For example, the openingmay comprise a v- or u-shaped recess 152, as shown in FIGS. 9A-9C. Inanother exemplary embodiment, however, an opening 154 may comprise ahole, bore, or another like aperture 156, as shown in first alternatestop 158 in FIGS. 10A-10C and second alternate stop 160 in FIGS.11A-11C. Accordingly, those of ordinary skill in the art will appreciatethat an opening 150, 154 may take any number of forms, each of whichremains within the spirit and scope of the present disclosure.

Referring to FIGS. 9A-9C and 10A-10C, the first alternate stop 158 maybe substantially the same as the stop 132, except for the differentopenings 150, 154. Referring to FIGS. 9A-9C, 10A-10C, and 11A-11C, thesecond alternate stop 160 may also be substantially the same as thefirst alternate stop 158, except the second alternate stop 160 maycomprise multiple pieces. For example, the second alternate stop 160 maycomprise a first piece 162 and a second piece 164. The first piece 162may include a first portion of the bore 156, the proximal face 138, thedistal face 140, and the end faces 146, 148 and the second piece 164 mayinclude a second portion of the bore 156, the proximal face 138, thedistal face 140, and the end faces 146, 148. Of course, otherconstructions of the stops 132, 158, 160 are possible and contemplated.

Any of the stops 132, 158, 160 may be used as the stop 132 ₁, 132 ₂ inthe deflection mechanism 42. Furthermore, the stops 132 ₁, 132 ₂ may bethe same (e.g., both stops 132 ₁, 132 ₂ may comprise a stop 132), or thestops may be different from each other (e.g., one stop 132 ₁ maycomprise a stop 132, and another stop 132 ₂ may comprise a firstalternate stop 158).

Although the adjustable stops 132, 158, 160 are generally illustratedand described as rectangular prisms with generally flat faces 138, 140,142, 144, 146, 148, other shapes of the adjustable stops 132, 158, 160are possible and contemplated. In an embodiment, the shape and contoursof an adjustable stop 132, 158, 160 may be designed according to theshape of the channel 64 and the shape and positions of the recesses 124,126 in the channel 64 (see FIGS. 3A-5B).

Returning to FIG. 3, in an exemplary embodiment, the wire locks 70 ₁, 70₂ are disposed within the channel 64 of the actuator body 48 and areconfigured, in certain instances, to ride (e.g., slide or glide) thereinas the actuator body 48 is rotated. Because the activation wires 50 ₁,50 ₂ are attached to the wire locks 70 ₁, 70 ₂, and the wire locks 70 ₁,70 ₂ are disposed within the channel 64, the activation wires 50 ₁, 50 ₂extend from the channel 64 and out of the actuator body 48 through theslot 60 thereof.

More particularly, and with reference to FIGS. 3A-6, in one exemplaryembodiment, the rotatable actuator body 48 comprises a base member 72and a cover member 74. As best shown in FIGS. 4 and 6, the base member72 comprises a first face 76, second face 78, and a transverse wall 80disposed between and substantially perpendicular to the first and secondfaces 76, 78. In an exemplary embodiment, the transverse wall 80 of thebase member 72 comprises the third outer wall 56 of the actuator body48, and a portion of the transverse wall 80 further comprises the firstportion 58 of the actuator body 48 having the slot 60 disposed therein.In such an embodiment, the first face 76 of the base member 72 maycomprise the second portion 62 of the actuator body 48 that comprisesthe channel 64 disposed therein or thereon. As such, the first face 76may comprise an inner surface of the first outer wall 52 of the actuatorbody 48, while the second face 78 may comprise an outer surface of thefirst outer wall 52.

Similar to the base member 72, in an exemplary embodiment such as thatillustrated in FIGS. 3A, 3B, and 6, the cover member 74 of the actuatorbody 48 comprises a first face 82, a second face 84, and a transversewall 86 disposed between and substantially perpendicular to the firstand second faces 82, 84. The cover member 74 is adapted to overlie thebase member 72, and the first face 82 of the cover member 74 is adaptedto be engaged with the first face 76 of the base member 72. As such, inan exemplary embodiment, the first face 82 of the cover member 74comprises an inner surface of the second outer wall 54 of the actuatorbody 48, while the second face 84 comprises an outer surface of thesecond outer wall 54. As will be described below, the cover member 74 isoperative to retain at least the wire locks 70 ₁, 70 ₂ and theadjustable stops 132 ₁, 132 ₂ within the channel 64.

With reference to FIGS. 4 and 5A, the base member 72 of the actuatorbody 48 is illustrated. The base member 72 comprises a first end 88 anda second end 90 opposite the first end 88. In an exemplary embodiment,the channel 64 is disposed at the first end 88 of the base member 72,while the slot 60 is disposed at the second end 90. Further, in anexemplary embodiment, the channel 64 comprises a curved channel. In suchan embodiment, and in an instance such as that illustrated in FIGS. 4and 5A wherein the transverse surface 80 comprises an annular surface,the channel 64 may have a degree of curvature that is substantially thesame as that of the transverse surface 80 of the base member 72.

In any event, and irrespective of whether the channel 64 is curved, thedegree of curvature, or where it is located, in an exemplary embodimentthe channel 64 comprises a substantially u- or v-shaped channel defined,at least in part, by first and second side walls 92, 94, and first andsecond end walls 96, 98. Each of the first and second end walls 96, 98are disposed between the first and second end walls 92, 94 at oppositeends of the channel 64. The first and second side walls 92, 94 may havea plurality of recesses 124, 126, as discussed above.

In an exemplary embodiment, at least one of the end walls 96, 98 mayhave an opening 100 disposed therein. In the embodiment illustrated inFIGS. 4 and 5A, each of the end walls 96, 98 has an opening 100 disposedtherein (i.e., the end wall 96 has an opening 100 ₁ disposed therein,while the end wall 98 has an opening 100 ₂ disposed therein). Theopenings 100 ₁, 100 ₂ are provided to allow for the extension of theactivation wires 50 ₁, 50 ₂ out from the channel 64 within which thewire locks 70 ₁, 70 ₂, and therefore, the proximal ends 66 of theactivation wires 50, are disposed. The openings 100 ₁, 100 ₂ may takeany number of forms. For example, one or both of the openings 100 ₁, 100₂ may comprise a v- or u-shaped notch formed in the respective end walls96, 98. In another exemplary embodiment, however, one or both of theopenings 100 ₁, 100 ₂ may comprise a hole or another like aperture inthe respective side walls 96, 98. Accordingly, those of ordinary skillin the art will appreciate that the openings 100 ₁, 100 ₂ may take anynumber of forms, each of which remains within the spirit and scope ofthe present disclosure. Regardless of the particular form of theopenings 100 ₁, 100 ₂, the openings 100 ₁, 100 ₂ have a size (e.g.,diameter) that is smaller than that of the wire locks 70 ₁, 70 ₂ so asto retain the wire locks 70 ₁, 70 ₂ within the channel 64, therebypreventing the wire locks 70 ₁, 70 ₂ from exiting the channel 64 throughthe openings 100 ₁, 100 ₂ if one or both of the adjustable stops 132 ₁,132 ₂ are not present.

With continued reference to FIG. 5A, in addition to the channel 64, inan exemplary embodiment the second portion 62 of the actuator body 48,which in the illustrated embodiment comprises at least a portion of thefirst face 76 of the base member 72, further comprises one or morepassageways 102 disposed therein or thereon extending from the slot 60in the first portion 58 (e.g., the transverse surface 80 of the basemember 72) to the opening(s) 100 in the channel 64. In an embodimentwherein the deflection mechanism 42 comprises a pair of activation wires50 ₁, 50 ₂, first and second passageways 102 ₁, 102 ₂ are formed in oron the first face 76 of the base member 72. In such an embodiment, thefirst passageway 102 ₁ extends from the slot 60 to the opening 100 ₁ inthe first end wall 96 of the channel 64, and the second passageway 102 ₂extends from the slot 60 to the opening 100 ₂ in the second end wall 98.In an embodiment such as that illustrated in FIG. 5A, the first andsecond passageways 102 ₁, 102 ₂ comprise first and second portions of alarger passageway or groove disposed in or on the first face 76 of thebase member 72. Alternatively, the first and second passageways 102 ₁,102 ₂ may be separate and distinct from each other (i.e., do notcomprise portions of a single larger groove or passageway).

As with the channel 64, in an exemplary embodiment, the passageways 102may have a curved shape. In such an embodiment, and in an instancewherein the transverse surface 80 comprises an annular surface, thepassageways 102 may have a degree of curvature that is substantially thesame as the degree of curvature of the transverse surface 80 of the basemember 72. Further, and as with the channel 64 and openings 100described above, in an exemplary embodiment, the passageways 102 ₁, 102₂ may comprise substantially u- or v-shaped passageways.

In an exemplary embodiment, each of the passageways 102 ₁, 102 ₂ has aconstant width along the length of the passageways 102 ₁, 102 ₂.Alternatively, and as best illustrated in FIG. 5, different portions ofthe passageways 102 ₁, 102 ₂ may have different widths. For example, inthe illustrated embodiment, each of the passageways 102 ₁, 102 ₂ has afirst portion 103 proximate the slot 60, and a second portion 104 thatis in closer proximity to the openings 100 ₁, 100 ₂, respectively, thanthe first portion 103. In an exemplary embodiment, the first portion 103has a width that is less than the width of the second portion 104. Assuch, each passageway 102 ₁, 102 ₂ has a shoulder 105 disposed thereinat the transition between the first and second portions 103, 104.Further, in an exemplary embodiment such as that illustrated in FIG. 5A,the first portion 103 defines a longitudinal centerline 106 that isoffset from a longitudinal centerline 107 defined by the second portion104. As a result, and as illustrated in FIG. 5A, while in an exemplaryembodiment the longitudinal centerlines of the openings 100 ₁, 100 ₂ arealigned with both the longitudinal centerline of the channel 64 and therespective longitudinal centerlines 107 of the second portions 104 ofthe passageways 102 ₁, 102 ₂, the respective centerlines 107 of thesecond portions 104 of the passageways 102 ₁, 102 ₂ are offset from therespective centerlines 106 of the first portions 103. More particularly,in an exemplary embodiment, the centerlines 106 of the first portions103 are offset from the centerlines 107 of the second portions 104 in adirection toward the third outer wall 56/transverse wall 80. One purposeof employing passageways 102 having varying widths and being arranged asdescribed above is to allow for a greater degree of deflection ascompared to other known deflection mechanisms wherein the centerlines ofthe openings in the channel are aligned with the centerline of thechannel 64 and the centerlines of the entire passageways 102 that has aconstant width along its length.

In the illustrated embodiment, each of the passageways 102 ₁, 102 ₂ areconfigured to have a respective one of the activation wires 50 ₁, 50 ₂extend therethrough. More particularly, and with reference to FIGS. 3A,3B, and 5A, the first activation wire 50 ₁ extends from the first wirelock 70 ₁ disposed in the channel 64, through the opening in theadjustable stop 132 ₁, through the opening 100 ₁ in the end wall 96 ofthe channel 64, through the first passageway 102 ₁, and out of theactuator body 48 through the slot 60 in the transverse surface 80 of thebase member 72. Similarly, the second activation wire 50 ₂ extends fromthe second wire lock 70 ₂ also disposed in the channel 64, through theopening in the adjustable stop 132 ₂, through the opening 100 ₂ in theend wall 98 of the channel 64, through the second passageway 102 ₂, andout through the slot 60.

As briefly described above, in an embodiment wherein the actuator body48 is of a two-piece construction comprising the base member 72 and thecover member 74, the cover member 74 may be operative to engage thefirst face 76 of the base member 72 and to retain the wire locks 70 ₁,70 ₂ and the adjustable stops 132 ₁, 132 ₂ in the channel 64. Moreparticularly, FIG. 6 depicts a cross-sectional view of a portion of theactuator body 48 illustrating the cover member 74 overlying the basemember 72, with the first face 82 of the cover member 74 being engagedwith the first face 76 of the base member 72 to retain the wire locks 70₁, 70 ₂ in the channel 64.

Similarly, in an exemplary embodiment wherein the end walls 96, 98 ofthe channel 64 have respective openings 100 ₁, 100 ₂, therein, and/orthe activation wires 50 ₁, 50 ₂ extend through the respectivepassageways 102 ₁, 102 ₂, the cover portion 74 is operative to retainthe activation wires 50 ₁, 50 ₂ in the openings 100 ₁, 100 ₂, and/or thepassageways 102 ₁, 102 ₂ in the same manner as that described above withrespect to the wire locks 70. Finally, in an exemplary embodiment, thecover member 74 may be still further operative to retain the activationwires 50 ₁, 50 ₂ in the slot 60 of the actuator body 48 in the samemanner as that described above.

Accordingly, once the wire locks 70, the adjustable stops 132 ₁, 132 ₂,and the activation wires 50 ₁, 50 ₂ are assembled with the base member72, in an exemplary embodiment, the base member 72 and the cover member74 may be coupled or affixed together using techniques that are wellknown in the art. For example, the base and cover members 72, 74 may becoupled together using press fit or interference coupling techniques, bycomplementary interlocking members disposed on each of the base andcover members 72, 74, by conventional fasteners or adhesives, or anyother techniques known in the art. Alternatively, the base and covermembers 72, 74 may not be coupled or affixed together at all, but rathermay be held or compressed together by virtue of the particularconstruction of the handle 12 and the nature in which it is assembled(e.g., the when the handle 12 is fully assembled, the base and covermembers 72, 74 are subjected to a compression force that is sufficientto hold the base and cover portions 72, 74 together as if they wereotherwise coupled or affixed together).

Whether the second portion 58 of the actuator body 48, which, again, inthe illustrated embodiment, comprises the base member 72 of the actuatorbody 48, includes only the channel 64 or both the channel 64 and thepassageways 102 ₁, 102 ₂, each the end walls 96, 98 of the channel 64are configured and operative to engage and apply a force onto arespective one of the wire locks 70 ₁, 70 ₂ when the actuator body 48 isrotated in a respective direction, if one or both of the adjustablestops 132 ₁, 132 ₂ are not included in the handle 24. Alternatively, ifthe adjustable stops 132 ₁, 132 ₂ are used, the stops 132 ₁, 132 ₂ areconfigured and operative to engage and apply a force onto a respectiveone of the wire locks 70 ₁, 70 ₂.

More particularly, and as illustrated in FIG. 3A, when the actuator body48 is in a neutral position (i.e., the shaft 14 of the catheter 10 is ina neutral or non-deflected state), the wire locks 70 ₁, 70 ₂ disposed inthe channel 64 are in contact with the adjustable stops 132 ₁, 132 ₂ or,if one or both of the adjustable stops 132 ₁, 132 ₂ are not used, one orboth of the wire locks 70 ₁, 70 ₂ may be in contact with end walls 96,98 of the channel 64, respectively. In an exemplary embodiment such asthat illustrated in FIG. 3B, when the actuator body 48 is rotated in afirst direction 108 (e.g., in a clockwise direction), the firstadjustable stop 132 ₁ (or, if the first adjustable stop 132 ₁ is notused, the first end wall 96) of the channel 64 is operative to engageand apply a force onto the first wire lock 70 ₁. The force applied ontothe first wire lock 70 ₁ by the stop 132 ₁ or the end wall 96 as theactuator body 48 is rotated clockwise causes tension to be applied tothe first activation wire 50 ₁ (i.e., the first activation wire 50 ₁ iscaused to be “pulled”). Conversely, as the actuator body 48 is rotatedin the first direction 108, the second stop 132 ₂ and the second endwall 98 of the channel 64 move away from the second wire lock 70 ₂ andtherefore, no force is applied onto the second wire lock 70 ₂. Rather,as illustrated in FIG. 3B, the second wire lock 70 ₂ rides within thechannel 64 as the actuator body 48 rotates in the first direction 108,thereby preventing the second activation wire 50 ₂ from being either“pushed” or “pulled.”

Similarly, the second stop 132 ₂ or the second end wall 98 of thechannel 64 are operative to engage and apply a force onto the secondwire lock 70 ₂ disposed in the channel 64 when the actuator body 48 isrotated in a second direction 109 opposite the first direction 108(e.g., in a counterclockwise direction). As with the first activationwire 50 ₁ described above, the force applied onto the second wire lock70 ₂ by the adjustable stop 132 ₂ or the end wall 98 as the actuatorbody 48 is rotated in the second direction 109 causes tension to beapplied to the second activation wire 50 ₂ (i.e., the second activationwire 50 ₂ is caused to be “pulled”). Conversely, as the actuator body 48is rotated in the second direction 109, the first stop 132 ₁ and thefirst end wall 96 of the channel 64 move away from the first wire lock70 ₁, and therefore, no force is applied onto the first wire lock 70 ₁.Rather, the first wire lock 70 ₁ rides within the channel 64 as theactuator body 48 rotates in the second direction 109, thereby preventingthe first activation wire 50 ₁ from being either “pushed” or “pulled.”

In order to facilitate the riding of the wire locks 70 within thechannel 64, in an exemplary embodiment such as that illustrated in FIGS.8A and 8B, the wire locks 70 have a substantially spherical shape. Itwill be appreciated, however, that the present disclosure is not meantto be limited to such an embodiment, but rather in other exemplaryembodiments that remain within the spirit and scope of the presentdisclosure, the wire locks 70 may have any number of shapes and suchembodiments remain within the spirit and scope of the presentdisclosure.

Referring to FIGS. 5B, 8A, and 8B, the channel 64 may have a diameterd₁, one or more of the recesses may have an opening diameter d₂, and thewire locks 70 may have a diameter d₃. To facilitate the riding of thewire locks 70 within the channel 64, the diameter d₃ of the wire locks70 ₁, 70 ₂ may be larger than the opening diameter d₂ and smaller thanthe diameter d₁ of the channel 64. In an embodiment, the ratio of thediameter d₃ of the wire locks to the recess opening diameter d₂ may beat least 4:1.

One advantage of the arrangement described above wherein the wire locks70 are configured to ride within the channel 64 is that bending orbuckling and weakening of the activation wires resulting from thepushing of the activation wires in a direction toward the catheter shaft14 is prevented. More particularly, one drawback of certain conventionaldeflection mechanisms such as those described elsewhere herein has beenwith respect to pushing forces being applied to the activation wiresthat are not being selectively tensioned. More particularly, in certainconventional deflection mechanisms, the actuator thereof comprises oneor more posts that are each configured to be coupled to the proximal endof a respective activation wire. For example, in an instance wherein thedeflection mechanism comprises a pair of activation wires, the actuatormay include a pair of posts, each one of which has a respective one ofthe activation wires coupled thereto. In such an instance, as theactuator is manipulated to deflect the shaft in a desired direction, apulling force is applied onto one of the activation wires, therebycausing tension to be applied to that activation wire. Meanwhile, theother activation wire that is not subjected to the pulling force may becaused to be pushed in the opposite direction of the pulling force, andinto, for example, the housing of the handle assembly. As a result ofthis pushing force, the activation wire being pushed may bend or buckle,thereby causing the activation wire to weaken and potentially fail(e.g., the activation wire may eventually snap).

In the present disclosure, because the wire locks 70 are configured toride within the channel 64 as tension is applied to one of theactivation wires 50 (i.e., the activation wire is “pulled” in thedirection away from the catheter shaft 14), the wire lock 70corresponding to the non-tensioned activation wire 50 is allowed to ridewithin the channel 64, and therefore, the non-tensioned activation wire50 is not caused to be pushed, and thus, bending or buckling andweakening of that activation wire 50 resulting from the pushing of theactivation wire 50 is prevented.

As briefly described above, and as illustrated in, for example, FIGS. 1,3A, and 3B, the deflection mechanism 42 is associated with the handle 12of the catheter 10. More particularly, in an exemplary embodiment, theactuator body 48 of the deflection mechanism 42 is rotatably mountedwithin a portion of the cavity 32 of the handle housing 24 and, in theillustrated embodiment, is disposed between the first and second pieces26, 28 of the housing 24. As illustrated in FIG. 2, in an exemplaryembodiment, the actuator body 48 has an aperture 110 extendingtherethrough configured to receive the post 34 of the handle housing 24.When the actuator body 48 is assembled with the post 34, the actuatorbody 48 is configured to rotate about the post 34.

In the illustrated embodiment wherein the catheter handle 12 comprisesfirst and second pieces 26, 28, once the actuator body 48 is positionedwithin the cavity 32 and onto the post 34 of the housing 24, the housing24 may be assembled together. More particularly, in an exemplaryembodiment, the second piece 28 of the housing 24 may be aligned withthe first piece 26 thereof and press fit together. As illustrated inFIG. 2, the handle 12 may further comprise an O-ring 111. The O-ring 111may be disposed between the actuator body 48 and the first outer wall 52thereof, in particular (which in one embodiment comprises the coverportion 74), and the inner surface of the housing 24 (which in oneembodiment comprises the inner surface of the second piece 28 of thehousing 24). As illustrated in FIGS. 1 and 2, in order to allow for aphysician to manipulate or rotate the actuator body 48, the housing 24of the handle 12 may further comprise one or more slots 112 thereinthrough which the actuator body 48 extends and within which the actuatorbody 48 may rotate. In the embodiment illustrated in FIGS. 1 and 2, thehousing 24 comprises a pair of slots 112 ₁, 112 ₂ disposed ondiametrically opposite sides of the housing 24.

Further, in an embodiment such as that illustrated in, for example,FIGS. 1 and 2, while the actuator body 48 may rotate within the slot(s)112 of the handle housing 24, it may comprise one or more protrusions114 extending outwardly therefrom (e.g., from the third outer wall56/transverse wall 80) that is/are configured to limit the extent towhich the actuator body 48 may be rotated. More particularly, in theillustrated embodiment, which includes a pair of protrusions 114 ₁, 114₂ disposed on diametrically opposite sides of the actuator body 48, theprotrusions 114 ₁, 114 ₂ extend outwardly a suitable distance such thatwhen the protrusions 114 ₁, 114 ₂ reach an end of the respective slots112 ₁, 112 ₂, they make contact with the housing 24, which therebyprevents the further rotation of the actuator body 48 in that particulardirection.

In addition to limiting the rotation of the actuator body 48, theprotrusions 114 ₁, 114 ₂ may further provide a means by which aphysician using the catheter 10 can determine when the shaft 14 is in aneutral or non-deflected state. For example, when the protrusions 114 ₁,114 ₂ are centered within the slots 112, the physician can tell that theshaft 14 is in a non-deflected state.

It will be appreciated that while the illustrated embodiment comprises apair of protrusions 114, the present disclosure is not meant to be solimited. Rather, in other exemplary embodiments that remain within thespirit and scope of the present disclosure, the body 48 may comprise asingle protrusion or more than two protrusions that serve the samefunction and purpose described above.

As briefly described above, the distal ends 68 of the activation wires50 ₁, 50 ₂ of the deflection mechanism 42 are attached to the pullassembly 44 disposed within the shaft 14 of the catheter 10. Theactivation wires 50 ₁, 50 ₂ may be attached to the pull assembly 44 inan number of ways that are well known in the art, such as, for exampleand without limitation, by soldering or otherwise adhering thecomponents together with a suitable adhesive. From the pull assembly 44,the activation wires 50 ₁, 50 ₂ extend through the shaft 14 to theproximal end portion 16 of the shaft 14. In an exemplary embodiment, theactivation wires are disposed within one or more lumens (not shown) inthe shaft 14. In any instance, and as illustrated in FIGS. 3A and 3B,the activation wires 50 ₁, 50 ₂ further extend from the proximal endportion 16 of the shaft 14 through the housing 24 of the handle 12, andthe cavity 32 thereof, in particular, and into the slot 60 of theactuator body 48. As briefly described above, in an exemplaryembodiment, the handle housing 24 may further comprise a pair of guidewalls 36 ₁, 36 ₂ extending or protruding from the inner surface 30 ofthe housing 24 (and, in an exemplary embodiment, the first or bottompiece 26 thereof, in particular) and into the cavity 32. Each of theguide walls 36 ₁, 36 ₂ is configured to act as a guide for a respectiveone of the activation wires 50 ₁, 50 ₂ as the wires 50 ₁, 50 ₂ extendfrom the proximal end portion 16 of the shaft 14 and into the slot 60 ofthe actuator body 48.

In an exemplary embodiment, the handle 12 may further comprise means bywhich the ability to rotate the actuator body 48 may be controlled. Forexample, in the embodiment illustrated in FIG. 2, the handle 12 mayinclude a tension knob 116 that is operative to increase or decrease thecompression force applied to the actuator 46, and therefore, increase ordecrease the ability to rotate the actuator body 48. One advantage ofsuch functionality is that once a physician has deflected the shaft 14 adesired amount, the physician may maintain the deflection by adjustingthe tension knob 116 to limit the ability to rotate the actuator body 48in either direction.

In an exemplary embodiment such as that illustrated in, for example,FIG. 2, in addition to the tension knob 116, the handle 12 may furthercomprise a screw 118 that is configured to be mated with a threadedrecess in the tension knob 116. In such an embodiment, the post 34 ofthe housing 24 may comprise a through-going bore 120, which may comprisea threaded bore, extending through the length of the post 34 and theouter surface of the housing 24 (e.g., through the outer surface of thefirst or bottom piece 26 of the housing 24). In such an embodiment, thehousing 24 further comprises an aperture 122 that is coaxially alignedwith the post 34, and the bore 120 thereof, in particular. In theillustrated embodiment, the aperture 122 is disposed in the second ortop piece 28 of the housing 24. When the screw 118 and the tension knob116 are assembled together, the shaft of the screw 118 extends throughthe bore 120, O-ring 111 (if applicable), and the aperture 122 in thehousing 24. The tension knob 116 is mated with the end of the shaft ofthe screw 118, such as, for example, by threading the tension knob 116onto the threaded shaft of the screw 118. Once assembled with the screw118, the tension knob 116 can be adjusted to increase or decrease thecompression force that is applied between the pieces 26, 28 of thehousing 24, and the various components disposed therebetween. Forexample, the tightening of the tension knob 116 may result in anincrease in the applied compression force, while the loosening of thetension knob 116 may result in a decrease in the compression force. Themore compression force that is applied, the more the ability to rotatethe actuator body 48 is limited.

As briefly described above, when assembled with the handle 12 and othercomponents of the catheter 10, the deflection mechanism 42, and theactuator 46 thereof, in particular, is configured to be selectivelymanipulated to cause the distal end portion 18 of the shaft 14 todeflect in one or more directions. More particularly, the manipulation(e.g., rotation) of the body 48 of the actuator 46 causes the selectivetensioning of the activation wires 50 ₁, 50 ₂, thereby effectingmovement of the pull assembly 44 (e.g., a pull ring), and thus, theshaft 14.

For example, in the embodiment illustrated in FIGS. 7A and 7B, when theactuator body 48 is rotated in a clockwise direction, the activationwire 50 ₁ is pulled in a direction that is away from the shaft 14 of thecatheter 10, thereby applying tension to the activation wire 50 ₁. Thetensioning of the activation wire 50 ₁ causes the pull assembly 44 to bepulled, resulting in the deflection of the shaft 14 in a firstdirection. Similarly, when the actuator body 48 is rotated in acounterclockwise direction, the activation wire 50 ₂ is pulled in adirection that is away from the shaft 14 of the catheter 10, therebyapplying tension to the activation wire 50 ₂. The tensioning of theactivation wire 50 ₂ causes the pull assembly 44 to be pulled, resultingin the deflection of the shaft 14 in a second direction that is oppositethe first direction.

Accordingly, the arrangement or configuration of the deflectionmechanism 42 described herein above permits the manipulation of theactuator 46 thereof to allow a physician to steer and navigate thecatheter 10 through the body of patient, while at the same timepreventing the pushing of the activation wires 50 toward the shaft 14 ofthe catheter 10 and into a portion of the cavity 32 of the handlehousing 24 that is forward of the actuator 46. As such, bending orbuckling and weakening of the activation wires 50 resulting from suchpushing of the activation wires 50 is prevented.

Although embodiments have been described above with a certain degree ofparticularity, those skilled in the art could make numerous alterationsto the disclosed embodiments without departing from the spirit or scopeof this disclosure. All directional references (e.g., upper, lower,upward, downward, left, right, leftward, rightward, top, bottom, above,below, vertical, horizontal, clockwise, and counterclockwise) are onlyused for identification purposes to aid the reader's understanding ofthe present disclosure, and do not create limitations, particularly asto the position, orientation, or use of the disclosure. Joinderreferences (e.g., attached, coupled, connected, and the like) are to beconstrued broadly and may include intermediate members between aconnection of elements and relative movement between elements. As such,joinder references do not necessarily infer that two elements aredirectly connected and in fixed relation to each other. It is intendedthat all matter contained in the above description or shown in theaccompanying drawings shall be interpreted as illustrative only and notlimiting. Changes in detail or structure may be made without departingfrom the spirit of the disclosure as defined in the appended claims.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A deflection mechanism for use in an elongatemedical device, comprising: an actuator comprising a rotatable body,said rotatable body comprising a channel, said channel comprising aplurality of recesses; an adjustable stop disposed in at least one ofsaid recesses; an activation wire having a proximal end and a distalend; and a wire lock attached to said proximal end of said activationwire; wherein said wire lock is disposed within said channel and isconfigured to ride therein when said actuator body is rotated so as toincrease tension on said activation wire when the actuator body isrotated in a first direction, and wherein said wire lock is furtherconfigured to move away from the adjustable stop when the actuator bodyis rotated in a second direction.
 2. The deflection mechanism of claim1, wherein said adjustable stop comprises an opening configured in sizeand shape to allow said activation wire to translate through saidopening and to prevent said wire lock from passing said stop.
 3. Thedeflection mechanism of claim 2, wherein said opening comprises a borethrough said adjustable stop.
 4. The deflection mechanism of claim 2,wherein said opening comprises a recess in a face of said stop.
 5. Thedeflection mechanism of claim 1, wherein each of said recesses comprisesan opening having a diameter that is smaller than a diameter of saidwire lock.
 6. The deflection mechanism of claim 5, wherein a ratio ofsaid diameter of said wire lock to said opening is at least 4:1.
 7. Thedeflection mechanism of claim 1, wherein said adjustable stop comprisesa rectangular prism.
 8. The deflection mechanism of claim 1, whereinsaid adjustable stop is a first adjustable stop, said activation wire isa first activation wire, and said wire lock is a first wire lock, thedeflection mechanism further comprising: a second adjustable stopdisposed in at least another of said recesses; a second activation wirehaving a proximal end and a distal end; and a second wire lock attachedto said proximal end of said second activation wire; wherein said secondwire lock is disposed within said channel and is configured to ridetherein when said actuator body is rotated so as to increase tension onsaid second activation wire.
 9. The deflection mechanism of claim 1,wherein said recesses are arranged in opposed pairs and said adjustablestop is disposed in two opposed recesses so as to span said channelgenerally perpendicular to a direction of translation of said activationwire.
 10. The deflection mechanism of claim 1, wherein said channel iscurved.
 11. The deflection mechanism of claim 1, wherein said recessesare squared.
 12. The deflection mechanism of claim 1, wherein said wirelock is spherical.
 13. A handle assembly for use in a steerable elongatemedical device, comprising: a housing defining a cavity; and adeflection mechanism, said deflection mechanism comprising: an actuatorcomprising a rotatable body at least a portion of which is disposedwithin said cavity of said housing, said rotatable body comprising achannel, said channel comprising a plurality of recesses; an activationwire having a proximal end and a distal end; a wire lock attached tosaid proximal end of said activation wire; and an adjustable stopdisposed in at least one of said recesses so as to apply a force to saidwire lock responsive to actuation of said actuator, wherein said channelis configured to allow placement of said adjustable stop at multiplelocations; wherein said wire lock is disposed within said channel and isconfigured to ride therein when said actuator body is rotated; whereinsaid wire lock is further configured to increase tension on saidactivation wire when the actuator body is rotated in a first direction,and wherein said wire lock is further configured to move away from theadjustable stop when the actuator body is rotated in a second direction;and further wherein said activation wire extends from said channel andinto said cavity of said housing.
 14. The handle assembly of claim 13,wherein said adjustable stop comprises an opening, said activation wireextending through said opening, said opening configured in size andshape to prevent said wire lock from passing said adjustable stop. 15.The handle assembly of claim 13, wherein said channel comprises aplurality of recesses configured to receive said adjustable stop, eachof said recesses comprising an opening having a diameter that is smallerthan a diameter of said wire lock.
 16. The handle assembly of claim 15,wherein said recesses are arranged in opposed pairs, wherein tworecesses in an opposed pair are configured to receive opposite ends ofsaid adjustable stop.
 17. The handle assembly of claim 16, wherein saidrecesses are squared, and said ends of said adjustable stop are squared.